Oral Retinoids (acitretin, alitretinoin, and isotretinoin): Reminder of restrictions to prevent exposure during pregnancy.

Oral retinoids are highly teratogenic. Use of oral retinoids is therefore contraindicated during pregnancy and in women of childbearing potential unless all of the conditions of the pregnancy prevention programme for these medicines are adhered to.

Recent studies conducted in a number of European countries revealed a low level of adherence to the measures of the pregnancy prevention programme for these medicines; pregnancies continue to occur in women treated with oral retinoids.

Women of childbearing potential should undergo medically supervised pregnancy tests shortly before starting treatment with oral retinoids and  monthly during treatment. These patients should also undergo medically supervised pregnancy tests for 1 month after stopping treatment with isotretinoin and alitretinoin and at 1 to 3 monthly intervals for 3 years after stopping treatment with acitretin.

Women of childbearing potential should use effective contraception, without interruption, for at least 1 month before initiating treatment and throughout the entire treatment. Effective contraception should be used for at least 1 month after stopping treatment with isotretinoin and alitretinoin, and for 3 years after stopping treatment with acitretin.

These measures apply to all women of childbearing potential, even sexually inactive patients (unless following the criteria outlined in the summary of product information).

Women who become pregnant must stop taking acitretin, alitretinoin or isotretinoin straight away and consult a doctor urgently.